The following data is part of a premarket notification filed by Medical Instruments Technology, Inc. with the FDA for Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited Reuse Blade, Arthroscopic Burs.
| Device ID | K012624 |
| 510k Number | K012624 |
| Device Name: | REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS |
| Classification | Arthroscope |
| Applicant | MEDICAL INSTRUMENTS TECHNOLOGY, INC. 385 NORTH 3050 EAST St. George, UT 84790 |
| Contact | Jack Speer |
| Correspondent | Jack Speer MEDICAL INSTRUMENTS TECHNOLOGY, INC. 385 NORTH 3050 EAST St. George, UT 84790 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-11-08 |
| Summary: | summary |